HighField Biopharma's mRNA HFG1 Shows Promise as Long-Acting GLP-1R Agonist for Diabetes and Weight Loss

HighField Biopharmaceuticals, a clinical-stage company based in Hangzhou, China, has announced promising results from a preclinical study involving naturally diabetic monkeys administered with HFG1, an mRNA-based GLP-1R agonist. The findings were shared during the American Diabetes Association (ADA) 84th Scientific Sessions held from June 21-24, 2024, in Orlando, Florida.

HFG1 is designed to treat diabetes by encoding a fusion protein that combines a GLP-1 analogue with a pH-sensitive binder of human FcRn. The mRNA is encapsulated in proprietary lipid nanostructure particles (LNPs), specifically engineered for subcutaneous administration, leading to localized mRNA delivery. The expressed proteins are then secreted and enter the systemic circulation.

The study, titled "Preliminary study of efficacy and duration of an mRNA based GLP-1R agonist in diabetic monkeys," was published on the ADA’s journal Diabetes website. The full poster was presented by HighField's CEO and Scientific Founder, Dr. Yuhong Xu. According to Dr. Xu, the results are encouraging, and the company plans to file a U.S. IND (Investigational New Drug) application for HFG1 by the third quarter of 2024.

The study revealed significant benefits for the diabetic monkeys following a single injection of HFG1. Over a two-month assessment period, the monkeys experienced weight loss and a reduction in HbA1c levels, a key marker for long-term blood glucose control. Importantly, no serious adverse effects were observed during the monitoring period. The monkeys did show a reduced appetite during the first week post-injection, which normalized thereafter.

Dr. Xu emphasized the innovative nature of their LNP technology, which incorporates membrane-stabilized structures. Unlike traditional LNPs used for mRNA vaccines, these structures are more stable during storage and post-injection. This stability allows for more sustained production of the therapeutic protein, extending the duration of GLP-1R agonist activity to weeks and months. Consequently, the need for frequent injections is significantly reduced compared to existing GLP-1 products.

HighField Biopharmaceuticals specializes in creating lipid-based therapeutics aimed at treating cancer, diabetes, and other diseases. The company operates a research and development center, along with a GMP-compliant production facility. Their leading clinical development program includes HFK16, a drug encapsulated in immune-modulating liposomes. Additionally, the company is developing an ADC platform consisting of drug-encapsulated immunoliposomes for solid tumors and LNP therapeutics for gene delivery and gene therapy.

In conclusion, the promising preclinical results of HFG1 in diabetic monkeys mark a significant milestone for HighField Biopharmaceuticals. The company’s innovative LNP technology has demonstrated potential in improving the efficacy and duration of mRNA-based therapeutics, paving the way for more effective and less burdensome treatments for diabetes. With plans to file a U.S. IND application in the upcoming third quarter, HighField is poised to advance its clinical development efforts, potentially offering new hope for patients with diabetes and other serious conditions.